1. Field of the Invention
The present invention relates generally to medical infusion and fluid sampling devices. More particularly, the invention concerns a safety enclosure for enclosing a hollow member, such as a hypodermic needle, or blunt cannula adapted for use with one or more injection sites disposed between two lengths of small plastic tubing.
2. Discussion of the Invention
Needle sticks have become an extremely serious problem. Approximately 40 percent of all pharmaceuticals used in hospitals are now administered by injection, either directly or through injection sites. Similarly, blood or other fluid sampling using hypodermic syringes and evacuated chambers has become common place. Accordingly, health-care workers are continuously exposed to needle sticks and to contaminated blood. Statistics show that most needle sticks occur during recapping of used needles, picking up and carrying the needle, placing needles in a receptacle, or when needles are inadvertently left at a patient's bedside.
Hepatitis-B has long been of great concern to clinicians. This concern was meaningfully addressed only after the recent epidemic of acquired immune deficiency syndrome (AIDS). As pointed out in the Aug. 4, 1988 issue of the New England Journal of Medicine, 319:284-288, the epidemic of the acquired immunodeficiency syndrome has led to great concern among health-care workers about all of the various risks they face in the hospital environment. Needle-stick injuries, in particular, have drawn attention, for despite safety guidelines and employee education, there is little evidence that their incidence is abating. While transmission of human immunodeficiency virus is unusual after a needle stick, nevertheless, infections in health-care workers have been attributed to this type of exposure. The potential medical and psychological consequences of needle sticks for health-care workers and their spouses or sexual partners remain great.
Studies concerning needle-stick injuries indicate that disposable syringes accounted for about 35 percent of the injuries and needle assemblies for another 26 percent. These types of devices are typically used in connection with the methods and apparatus for fluid administration and blood or other fluid sampling. More particularly, these types of devices are used in connection with an apparatus for arterial and venous blood sampling of the character sold by Abbott Laboratories of Mountain View, Calif., Telos Medical of Upland, Calif., or Concord/Portex of Keene, N.H. Additionally, one form of the device of the invention is uniquely usable with an improved apparatus for arterial and venous blood sampling invented by the present inventor and described in U.S. Pat. No. 4,763,648.
Each of the commercially devices described in the preceding paragraph comprises an injection site including a body having a fluid chamber and spaced apart fluid ports adapted to be connected to plastic tubing. The upper chamber is adapted to be sealed by a septum penetratable by a penetration member such as a blunt cannula or a needle of a syringe. As will be better understood from the description which follows, the device of the present invention is usable with the devices of the character just described and uniquely carries a penetration member disposed interiorly of a novel shroud portion which is adapted to be closely received over the body of the injection site and interlocked to the tubing. Following the injection or sample step, the skirt portion can be quickly unlocked from the tubing, removed from the body and safely sealed by a novel interlocking closure cap.